MAUDE Adverse Event Report: INOVONICS WIRELESS CORPORATION ARIAL WIRELESS WATER-RESISTANT PENDANT ES W/NECK LANYARD

Model Number	EN1221S-60
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
None.
Event or Problem Description
Ra responded to a call from the resident found between bed and bath.She said that she hit her head and was transferred to the hospital.Staff did respond to pendant push around 7:30 pm.After last med pass at 10:00 pm after the nurse walked out resident stated that they pushed pendant at that time and it shows that pendant was pushed but resetting within one minute.Resident did go to er and is having back issues.She stated that they did not receive any pages for the alarm.

• Brand Name: ARIAL WIRELESS WATER-RESISTANT PENDANT ES W/NECK LANYARD
• Common Device Name: ARIAL WIRELESS WATER-RESISTANT PENDANT ES W/NECK LANYARD
• Manufacturer (Section D): INOVONICS WIRELESS CORPORATION; 11000 westmoor cir building 10; suite 250; westminster CO 80021
• MDR Report Key: 19634065
• Report Number: 1929691-2024-00002
• Device Sequence Number: 8673856
• Product Code: IQA
• UDI-Device Identifier: 00840948100642
• UDI-Public: 00840948100642
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EN1221S-60
• Device Catalogue Number: EN1221S-60
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/24/2024
• Event Location: Nursing Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female